MAUDE MDR 4871070

MDR report key
4871070
Report number
1718791-2015-00001
Event key
0
Event type
3
Date of event
2015-05-22
Date received
2015-06-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. NICHOLAS LEE
Address
565 NUCLA WAY, UNIT B AURORA CO 80011 US
Phone
303-303-3033
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TEN20 CONDUCTIVE PASTETEN20D. O. WEAVER AND COMPANYGYB10-20-XX10-20-XXUNKN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-2601. O

Event Narratives#

D

Patient 1

PATIENT EXPLAINED THAT SHE HAD A MULTIPLE SLEEP LATENCY TEST (MSLT) TO CONFIRM NARCOLEPSY. THE TEST OCCURRED FROM 9:00 PM THURSDAY (B)(6) ENDING AT 4:00 PM FRIDAY (B)(6). THAT NIGHT OR EARLY THE NEXT DAY - SATURDAY (B)(6), PATIENT BEGAN TO EXPERIENCE A SEVERE SKIN IRRITATION ON HER SCALP, BEHIND HER EARS, WITH THE MOST SEVERE AREAS BEING ALONG THE JAWLINE WHICH HAVE SPREAD TOWARD HER LIPS. THE PATIENT INDICATED THAT THE SCALP IRRITATION AND THE RASH BEHIND HER EARS ARE NEARLY GONE, BUT THE RASH SPOTS DESCRIBED AS "HIVE-LIKE IN APPEARANCE WITH SMALL WHITE PIMPLES" REMAIN ON HER FACE ESPECIALLY THE JAWLINE. PATIENT WAS ADVISED TO SEE HER DOCTOR IMMEDIATELY TO PREVENT FURTHER SPREADING OF THE RASH AND TO RECEIVE RELIEF AND APPROPRIATE TREATMENT. PATIENT RESPONDED BY SAYING SHE WILL "SEE IF SHE CAN GET IN TO SEE THE DOCTOR, PROBABLY NOT TODAY, BUT MAYBE WITHIN THE NEXT DAY OR SO." SHE DID AGREE TO PHONE BACK ONCE SHE HAS SEEN HER DOCTOR TO INFORM US OF THE PROGNOSIS.

N

Patient 1

PATIENT NEVER CALLED BACK LIKE SHE SAID SHE WOULD. WE HAVE ATTEMPTED TO CONTACT HER MULTIPLE TIMES TO ASCERTAIN HER CURRENT STATUS, BUT SHE HAS NOT RETURNED OUR PHONE CALLS. IF WE RECEIVE ANY ADDITIONAL INFORMATION, WE WILL SUBMIT A FOLLOW-UP REPORT. WE ARE AWARE THAT A VERY SMALL PERCENTAGE OF THE POPULATION MAY REACT NEGATIVELY TO TOPICAL PRODUCTS, LIKELY DUE TO HYPERSENSITIVE SKIN AND/OR ALLERGIES. IT IS VERY RARE THAT PERMANENT SCARRING RESULTS.